CLIENT SUCCESS STORIES

Proven Regulatory Solutions for MedTech & IVDs

Real Results

Trusted Partnerships

Audit-Ready Outcomes

Building Sustained MDR Audit Readiness
Clinical Evaluation Alastair Selby Clinical Evaluation Alastair Selby

Building Sustained MDR Audit Readiness

Innova moved from regulatory risk to sustained MDR audit readiness by remediating hundreds of clinical documents and restoring confidence across the business. This case study explores how a pragmatic regulatory partnership with SciMed helped stabilise compliance and reduce notified body friction.

Read More
Achieving EU MDR Compliance at Scale
Clinical Evaluation Alastair Selby Clinical Evaluation Alastair Selby

Achieving EU MDR Compliance at Scale

Discover how Caristo Diagnostics have been achieving seamless EU MDR compliance since 2019 without hiring internal clinical staff. By partnering with SciMed, they secured 100% CER approval rates, streamlined updates, and reliable audit readiness; while focusing their resources on innovation, not regulation.

Read More

Explore how leading medical device and IVD companies have achieved compliance, scaled regulatory activities, and navigated complex EU and UK requirements with SciMed's expert support.

These case studies highlight:

  • Practical solutions for MDR and IVDR compliance challenges

  • Scalable strategies that support growth without expanding internal teams

  • Evidence of long-term value through post-market support and clinical evaluations

Whether you're preparing a Clinical Evaluation Report or building a Post-Market Surveillance strategy, see how others have made it work; with SciMed by their side.